In this Friday’s PCT Grand Rounds, Richelle Koopman of the University of Missouri will present “Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension.” The Grand Rounds session will be held on Friday, May 12, 2023, at 1:00 pm eastern. Dr. Koopman is professor and vice chair for ...

The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5-day preconference workshop at the 2023 Annual Research Meeting in Seattle, Washington. The workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings,” will cover the essentials of embedded healthcare systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary ...

In this Friday’s PCT Grand Rounds, Joshua Denny of the All of Us Research Program at NIH, will present “All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine.” The Grand Rounds session will be held on Friday, May 5, 2023, at 1:00 pm eastern. Dr. Denny is the chief executive ...

The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “Intervention Delivery and Complexity,” illustrates that—although an intervention may be simple—the actual delivery of the intervention may be complex due to factors such as new workflows, special training of frontline staff, and the number of components ...

In this Friday’s PCT Grand Rounds, Matthew Semler of Vanderbilt University will present “Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-Crossover Trial.” The Grand Rounds session will be held on Friday, April 28, 2023, at 1:00 pm eastern. Dr. Semler is an assistant professor of medicine and bioinformatics and the medical director ...

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Drs. Russell Rothman, Erin Holve and Lesley Curtis continue their discussion about PCORnet – From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®. The full March 24 Grand Rounds webinar with Drs. Rothman and Holve is also available.

An upcoming webinar in the NIH HEAL Initiative’s HEAL Headliners series will highlight the experiences of 2 projects in meaningfully engaging patients and community partners throughout the research process to ensure that the findings have the greatest public health impact. The webinar will be held on Friday, May 5, 2023, at 2:00 pm eastern. Rosemarie Martin ...

The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5 day pre-conference workshop at the 2023 Annual Research Meeting in Seattle, Washington. The workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials Workshop,” will provide an introduction to the investigative opportunities for embedded health systems ...

In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine & Dentistry will present “Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-Randomised Trial.” The Grand Rounds session will be held on Friday, April 21, 2023, at 1:00 pm eastern. Dr. Garg is a professor ...

In this Friday’s PCT Grand Rounds, Kanecia Zimmerman of Duke University will present “RECOVER in Action: Status of Clinical Trial Protocols.” The Grand Rounds session will be held on Friday, April 14, 2023, at 1:00 pm eastern. Dr. Zimmerman is an associate professor of pediatrics in the Duke University School of Medicine. The Researching COVID to ...

The NIH National Center for Advancing Translational Sciences (NCATS) recently announced a new Request for Information (RFI) entitled, “Advancing Clinical and Translational Science Through Accelerating the Decentralization of Clinical Trials.” The goals of the RFI are to identify ways that decentralized clinical trials can help make trials more effective, efficient, and equitable. In particular, comments ...

Dr. Fan Li, a member of the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core since 2013, has received approval of a 3-year funding award from the Patient-Centered Outcomes Research Institute (PCORI) to develop causal inference methods for stepped-wedge cluster randomized trials—a design that has been increasingly adopted in pragmatic trials. Li is an ...

The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “Ethical Considerations of Data Sharing in Pragmatic Clinical Trials,” describes human subjects research regulations that may impact sharing data from embedded pragmatic clinical trials (ePCTs) and the ethical considerations for respecting the interests of ...

In this Friday’s PCT Grand Rounds, Srinath Adusumalli of the University of Pennsylvania will present “A Nudge Towards Cardiovascular Health: Applications of Behavioral and Implementation Science in Cardiovascular Medicine.” The Grand Rounds session will be held on Friday, April 7, 2023, at 1:00 pm eastern. Dr. Adusumalli is an adjunct assistant professor of medicine and an ...

The NIH Pragmatic Trials Collaboratory is pleased to announce the latest resource as part of its Quick Start Guide series. These Quick Start Guides are intended to support the successful conduct of embedded pragmatic clinical trials (ePCTs). The ePCT Quick Start Guide for Project Managers links to resources for project managers to support the conduct ...

In this Friday’s PCT Grand Rounds, Jody Cioliono will present “Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension (QUARTET USA): Results From a Randomized Controlled Trial.” The Grand Rounds session will be held on Friday, March 31, 2023, at 1:00 pm eastern. The QUARTET USA trial tested a novel approach to lowering blood pressure ...

The American Journal of Bioethics (AJOB) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinical trials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core. Unlike AJOB‘s typical Open Peer Commentaries, commentaries for the special issue may be ...

In this Friday’s PCT Grand Rounds, Erin Holve, Russell Rothman, Schuyler Jones, and Neha Pagidipati will present “From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®.” The Grand Rounds session will be held on Friday, March 24, 2023, at 1:00 pm eastern. Holve is the chief research infrastructure officer for PCORI. ...

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Michael Gibson and Dr. Adrian Hernandez continue their discussion about The Heartline Trial and a new paradigm for virtual clinical trials. The full February 17 Grand Rounds webinar with Dr. Gibson is also available.

In this Friday’s PCT Grand Rounds, Ethan Basch of the University of North Carolina at Chapel Hill will present “Patient-Reported Outcomes for Symptom and Adverse Event Monitoring in Oncology.” The Grand Rounds session will be held on Friday, March 17, 2023, at 1:00 pm eastern. Basch is the Richard M. Goldberg Distinguished Professor of Medical Oncology ...

IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Trial, enrolled its first study participant this week. Congratulations to the IMPACt-LBP study team for reaching this important project milestone! Led by investigators at Duke University and Dartmouth University, IMPACt-LBP is a cluster randomized trial of a multidisciplinary collaborative team approach for low back pain versus usual care. In the ...

In this Friday’s PCT Grand Rounds, Brennan Kahan of University College London will present “Estimands in Cluster-Randomized Trials: Choosing Analyses That Answer the Right Question.” This session is sponsored by the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core Working Group. The Grand Rounds session will be held on Friday, March 10, 2023, at 1:00 ...

In the March 16 session of IMPACT Grand Rounds, the NIA IMPACT Collaboratory will host Dr. Eleanor Murray, who will present on the topic of causal inference in pragmatic trials. From the announcement: Join us for IMPACT Grand Rounds on Thursday, March 16 at 12pm ET with Dr. Murray who will be presenting on the “Causal Inference in Pragmatic Trials.” Eleanor ...

In this Friday’s PCT Grand Rounds, Dr. Margaret Kuklinski and Dr. Stacy Sterling will present “Adoption, Implementation and Sustainment of Family-Focused Prevention in Health Care Systems: How Do We Get There?” Kuklinski and Sterling are the principal investigators of GGC4H, an NIH Pragmatic Trials Collaboratory Trial. The Grand Rounds session will be held on Friday, March ...

The Society for Medical Decision Making (SMDM) will host a free, live webinar on Thursday, March 2, to discuss equity and patient engagement. The webinar, “Equity in Medical Decision Making: Perspectives from Patient Partners and SMDM Members,” was organized by the SMDM Patient Advisory Council. From the announcement: In this webinar we will discuss equity, what it ...

The National Institute on Drug Abuse (NIDA) invites primary care clinical and research teams to take part in a new Challenge competition funding opportunity, “Substance Use Prevention Services in Primary Care!” With this Challenge, NIDA is seeking better understanding of how primary care providers can implement substance use prevention interventions in their clinical settings. The Challenge ...

In this Friday’s PCT Grand Rounds, Dr. Konstantin Dragnev and Dr. Karen Reckamp will present “S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials.” The Grand Rounds session will be held on Friday, February 24, 2023, at 1:00 pm eastern. S2302 Pragmatica-Lung is pragmatic clinical trial testing the effect of ramucirumab and ...

In this Friday’s PCT Grand Rounds, Dr. C. Michael Gibson of Harvard Medical School will present “The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials.” The Grand Rounds session will be held on Friday, February 17, 2023, at 1:00 pm eastern. Gibson is a professor of medicine at Harvard Medical School, an interventional cardiologist at ...

Dr. Fan Li, a member of the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core, will present “Methods for Designing Cluster Randomized Trials to Detect Treatment Effect Heterogeneity” during IMPACT Grand Rounds on Thursday, February 16, at 12:00 pm eastern. IMPACT Grand Rounds is hosted by the NIA IMPACT Collaboratory. Fan Li, PhD, is an ...

We are pleased to announce that our workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials,” will be available virtually and at no charge to all HCSRN Annual Conference registrants and all HCSRN members on the day preceding the conference in Denver. (This offering does not affect HCSRN Annual Conference programming, which ...

This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Pearl O’Rourke, Dave Wendler, Miguel Vazquez, and Michael Ho will present “Informing and Consenting: What Are the Goals?” The Grand Rounds session will be held on Friday, February 10, 2023, at 1:00 pm eastern. O’Rourke ...

The US Food and Drug Administration last week issued draft guidance for the use of “externally controlled clinical trials” to provide evidence of the safety and effectiveness of drugs and biologics. An externally controlled trial uses patient-level data from a source outside the clinical trial—such as a registry, electronic health records, or administrative claims data—to ...

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Emily Largent and Dr. Stephanie Morain continue their discussion about the ethical considerations for vulnerable populations participating in pragmatic clinical trials. The full January 13 Grand Rounds webinar with Dr. Largent is also available.

The Johns Hopkins Berman Institute of Bioethics is accepting applications for its 2023-2024 Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. This position includes pursuing independent research, ...

The NIH Pragmatic Trials Collaboratory has developed an online tool to evaluate the complexity of delivery of a trial intervention. To develop the tool, principal investigators of embedded pragmatic clinical trials (ePCTs) shared critical drivers of complexity that affected their ability to implement an intervention and discern treatment effects. An article describing the tool and its ...

In this Friday’s PCT Grand Rounds, Professor Luregn Schlapbach of the University Children’s Hospital Zurich will present “Pragmatic Trials for Children With Congenital Heart Disease: Insights From the NITRIC Trial.” The Grand Rounds session will be held on Friday, February 3, 2023, at 1:00 pm eastern. Schlapbach is head of intensive care and neonatology at the University ...

In an article published today in the Annals of Internal Medicine, leaders of the NIH Pragmatic Trials Collaboratory suggest that data sharing is not rising to its potential, and that more guidance is needed to prevent data sharing from becoming a “box-checking exercise.” “NIH should consider guidance to help investigators and NIH institutional centers understand what ...

The NIA IMPACT Collaboratory is seeking letters of intent from interested applicants for Cycle 5A of its Pilot Grants Program. The 1-year pilot grant awards will fund up to $175,000 in direct costs for pilot studies that aim to generate preliminary data for full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons ...

The NIH Pragmatic Trials Collaboratory began 2023 with 2 new Core Working Groups focused on health equity and implementation science. The membership of both Cores draws from across the program to support the design and implementation of the NIH Collaboratory Trials. “By launching these 2 new Core Working Groups, the NIH Pragmatic Trials Collaboratory is reaffirming ...

In this Friday’s PCT Grand Rounds, Dr. Derek Russell of the University of Alabama at Birmingham and Dr. Matthew Semler of Vanderbilt University will present “The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure.” The Grand Rounds session will be held on Friday, January 27, 2023, at 1:00 pm eastern. Russell ...

The INSPIRE NIH Collaboratory Trial went live this month, with a new order entry screen being activated in the electronic health record at 51 hospital sites randomized to the intervention. Congratulations to lead investigator Dr. Shruti Gohil, co–principal investigators Dr. Susan Huang and Dr. Richard Platt, and the INSPIRE team! INSPIRE is studying the effectiveness of a personalized ...

In this Friday’s PCT Grand Rounds, Mikhail Kosiborod of the University of Missouri-Kansas City will present “Collaborative Pragmatic Trials in Action: EVOLVE-MI.” The Grand Rounds session will be held on Friday, January 20, 2023, at 1:00 pm eastern. Kosiborod is a cardiologist, the vice president of research at Saint Luke’s Health System, and a professor of medicine ...

This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Emily Largent will present “Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials.” The Grand Rounds session will be held on Friday, January 13, 2023, at 1:00 pm eastern. Dr. Largent is the Emanuel ...

In this Friday’s COVID-19 Grand Rounds, Dr. Carolyn Bramante and Dr. Thomas Murray of the University of Minnesota will present “Outpatient Treatment of COVID-19 With Metformin, Ivermectin, or Fluvoxamine: 10-Month Follow-up and Effects on Developing Long COVID.” The Grand Rounds session will be held on Friday, January 6, at 1:00 pm eastern. Join the online meeting. The ...

The Health Care Systems Research Network (HCSRN) extended the early-bird registration deadline for its 2023 annual conference in Denver, Colorado, to January 9. The discounted registration rate will apply through this date. The NIH Pragmatic Trials Collaboratory will offer a full-day preconference workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials.” The workshop ...

In this Friday’s PCT Grand Rounds, Alex Spyropoulos and Jeffrey Solomon of the Feinstein Institutes for Medical Research will present “The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients.” The Grand Rounds session will be held on Friday, December 16, 2022, at 1:00 pm eastern. Spyropoulos is a professor of medicine ...

Investigators from the NIH Pragmatic Trials Collaboratory in 2022 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the Distributed Research Network, and study designs and results from the NIH Collaboratory Trials. This year, the NIH ...

This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Monica Taljaard and David Magnus will present “The Stepped Wedge Cluster Randomized Trial: Friend or Foe?” The Grand Rounds session will be held on Friday, December 9, 2022, at 1:00 pm eastern. Taljaard is a ...

In this Friday’s PCT Grand Rounds, Dr. Michael Felker of Duke University will present “A Randomized Controlled Trial of a Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned.” The Grand Rounds session will be held on Friday, November 18, 2022, at 1:00 pm eastern. Felker is a professor of medicine in the Duke University ...

The NIH Pragmatic Trials Collaboratory is excited to welcome the INSPIRE NIH Collaboratory Trial to its portfolio of innovative, large-scale pragmatic clinical trials embedded in healthcare systems. INSPIRE (or Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) will implement the INSPIRE-ASP Trials for Abdominal and Skin and Soft Tissue Infections. These 2 cluster ...